Bellerophon Therapeutics (NSDQ:BLPH) has enrolled the first patient in a Phase IIb study assessing its INOpulse device in patients with pulmonary hypertension due to interstitial lung disease. The company’s placebo-controlled study is slated to evaluate the safety and efficacy of pulsed, inhaled nitric oxide in patients with PH-ILD, including those with idiopathic pulmonary fibrosis, Bellerophon reported. […]
Clinical Trials
Mylan, Momenta take aim at Regeneron’s Eylea with biosimilar
Momenta Pharmaceuticals (NSDQ:MNTA) and Mylan (NSDQ:MYL) announced yesterday that they plan to launch a pivotal trial in the first half of 2018 for a proposed biosimilar to Regeneron‘s (NSDQ:REGN) blockbuster drug, Eylea. Eylea, a VEGF-inhibitor designed to treat wet age-related macular degeneration and diabetic macular edema, has little competition on today’s market. The drug brought in more than $5 […]
Gore launches FDA IDE Excluder conformable AAA endoprosthesis trial
W.L. Gore & Associates today announced the first implant of its Gore Excluder conformable abdominal aortic aneurysm endoprosthesis in the US as part of an FDA-approved investigational clinical study. The procedure was performed on December 19 at New York’s Maimonides Medical Center by national principal investigator Dr. Robert Rhee. “Patients with extreme proximal neck anatomies often […]
Glaukos seeks FDA IDE nod for iStent infinite trial
Glaukos (NYSE:GKOS) said today it submitted an investigational device exemption application to the FDA as it looks to launch a study of its iStent infinite trabecular micro-bypass system. The San Clemente, Calif.-based company’s iStent infinite is designed to reduce elevated intraocular pressure in patients with refractory glaucoma, and includes three heparin-coated titanium stents and an auto-injection […]
InVivo to end Inspire trial despite meeting primary endpoint, plans new study
InVivo Therapeutics (NSDQ:NVIV) today released updated results from the Inspire study of its neuro-spinal scaffold but said that it would not be reopening enrollment, which it paused last July, and is instead looking to a new randomized controlled trial to supplement the results. The Cambridge, Mass.-based company said that 43.8% of the 16 living patients in the […]
Corindus joins with Mayo Clinic in study of tele-robotic stenting
Corindus Vascular Robotics (OTC:CVRS) said today it is working with the Mayo Clinic to launch preclinical studies exploring the use of telestenting, a robotic treatment for percutaneous coronary interventions which can be operated by physicians in remote locations. The Waltham, Mass.-based surgical robotics company said that there is a global shortage of PCI-capable operators, and that telestenting […]
Attune Medical touts Enso esophageal temp management device study data
Attune Medical today released results from a clinical study of its Enso esophageal temperature management device, touting that its ability to supplement surface warming and catheter-based cooling devices and to provide warming in procedures not amenable to surface warming. Results from the study were published in the journal Anesthesia & Analgesia, the Chicago-based company said. […]
RenalGuard Solutions touts first-in-man heart failure device study results
RenalGuard Solutions today touted results from a first-in-man feasibility study of its RenalGuard System designed to manage fluids during diuretic therapy to treat congestive heart failure in patients suffering from fluid overload. Results from the trial were presented at the annual Devices in Heart Failure congress in Berlin, Germany, the Milford, Mass.-based company said. The […]
Frequency touts first-in-human safety study for hearing loss therapy
Frequency Therapeutics has finished a first-in-human study of its progenitor cell activation therapy, FX-322, in nine adults with severe to profound sensorineural hearing loss. The company’s candidate is a combination of small molecules that are designed to activate progenitor cells and trigger the formation of new hair cells in the inner ear. Get the full story […]
Nemaura readies CE Mark submission for non-invasive glucose monitor
Nemaura Medical (OTC:NMRD) finished the European clinical trial program for its non-invasive glucose monitoring system earlier this month and reported that it’s preparing to submit the product for CE Mark clearance in the E.U. The company’s clinical trial program in Europe included 75 patients who wore sugarBeat continuously for up to 14 hours over 7 consecutive […]
Study: Legacy pacers, ICDs found safe for 1.5T MRI scans
Pacemakers and implantable cardioverter defibrillators not marked as MRI-safe could still be mostly safe to use during imaging sessions with 1.5T MRI machines, according to a new study reported on by Healio. Results from the study were recently published in The New England Journal of Medicine. In the prospective, nonrandomized study, researchers aimed to explore […]